Zuben E Sauna is a Principal Investigator and product reviewer with the US Food and Drug Administration. His research interests lie in the next generation of therapeutic proteins and in pharmacogenetics. A key focus of his research activities has been to understand the pharmacogenetic basis of the immune response to protein therapeutics, which can significantly affect the efficacy and safety of these drugs. Chava Kimchi-Sarfaty is a Principal Investigator, product reviewer and Associate Director of Research at the Office of Tissues and Advanced Therapies, US Food and Drug Administration. Her research interests lie in the role of synonymous mutations in the human health and disease. Her pioneering work demonstrated that synonymous mutations, once considered “silent” can affect protein structure and function. Today numerous diseases and drug susceptibilities are associated with synonymous mutations.